Viral Infections

August 28, 2017

ViraCyte announced publication of positive data from a phase II clinical trial evaluating Viralym-M. Viralym-M was administered in 38 stem cell transplant patients with 45 different viral infections. All patients had either failed, not responded to or were unable to tolerate standard antiviral therapy. Viralym-M achieved a 92% overall clinical response after a single infusion and demonstrated efficacy against all five targeted viruses with the following cumulative response rates in infections refractory to standard therapy: 100% for BK virus (n=16), 94% for cytomegalovirus (n=17), 71% for adenovirus (n=7), 100% for Epstein-Barr virus (n=2) and 67% for human herpesvirus-6 (n=3). Thirty-one patients were treated for a single viral infection and seven patients were treated for multiple simultaneous infections. Notably, rapid disease alleviation was reported in patients with BK-associated hemorrhagic cystitis (BK-HC), which can cause incapacitating pain, significant blood loss, and potentially renal failure. There are no current FDA-approved therapies for BK-HC. Viralym-M infusions were safe with only two cases of new onset grade one graft-versus-host disease observed, both of which resolved with standard treatment.

January 11, 2016

Kamada has released results of a phase II/III study of human rabies immune globulin (IgG or KamRAB or KedRAB) therapy as a post-exposure treatment for rabies. The clinical trial was a prospective, randomized, double-blind, non-inferiority study of 118 healthy subjects. The study evaluated pharmacokinetic (PK) parameters of anti-rabies IgG levels in serum at different time points and assessed whether Kamada’s IgG interferes with the development of self-active antibodies. In addition, safety and tolerability were assessed. The trial’s primary endpoint measured the anti-rabies titer on day 14 as well as on additional time points for secondary endpoints, following drug infusion and infusion of an active vaccine as recommended by the standard-of-care. The primary endpoint was designed to determine non-inferiority with a -10% margin. Top-line results showed that the primary endpoint of non-inferiority was met with a difference of -1.8% between the two therapies with variability between -8.2% and 3.1% (90% confidence limit). Results showed that Kamada’s IgG was safe and well-tolerated with no drug-related serious adverse events (SAEs) experienced. The company expects to file a Biologics License Application (BLA) with the FDA in mid-2016. 

February 24, 2014

Sarepta Therapeutics reported results of a phase I trial of AVI-7288 in healthy volunteers for the treatment of Marburg virus infection. The phase I clinical study was a randomized, doubleblind, placebo-controlled trial that enrolled 40 healthy adult volunteers, and was designed to characterize the safety, tolerability and pharmacokinetics of AVI-7288 after daily repeat dosing. In each of five cohorts, six subjects received AVI-7288 and two subjects received placebo, daily for 14 days. AVI-7288 was well-tolerated through the highest dose tested, 16mg/kg per day, with no reported serious or clinically significant adverse events. An independent Data and Safety Monitoring Board reviewed blinded safety results from the study and recommended continued clinical development of AVI-7288.

February 25, 2013

Gilead Sciences issued results from a phase III trial of nucleotide sofosbuvir plus ribavirin (RBV) in chronic hepatitis C virus (HCV). This randomized study, FUSION, enrolled treatment-experienced patients with genotype 2 or 3 chronic HCV infection who failed prior treatment. Subjects received either a 12-week (n=103) or 16-week (n=98) course of sofosbuvir 400mg/day plus RBV (1,000mg/day or 1,200mg/day). The study met its primary efficacy endpoint of superiority compared to a predefined historic control sustained virologic response (SVR) rate of 25%. In FUSION, 50% of patients (n=50/100) in the 12-week arm and 73% of patients (n=69/95) in the 16-week arm achieved SVR12 (p<0.001 for both arms). In the 12-week arm, SVR12 rates were 86% among genotype 2 and 30% among genotype 3 patients. In the 16-week arm, SVR12 rates were 94% among genotype 2 and 62% among genotype 3 patients. Among the 34% of FUSION participants who had compensated cirrhosis at baseline, 31% achieved SVR12 in the 12-week arm, and 66% achieved SVR12 in the 16-week arm. All patients in the study became HCV negative on treatment, and relapse accounted for all virologic failures. The drug was well tolerated. The most frequent adverse events were fatigue, headache, insomnia and nausea. Based on these data plus results from three other phase III studies, Gilead is on track to file regulatory applications in the U.S. and Europe in the second quarter.